|Publication number||US6912424 B2|
|Application number||US 09/751,382|
|Publication date||Jun 28, 2005|
|Filing date||Dec 29, 2000|
|Priority date||Dec 1, 1999|
|Also published as||US20010021869, US20050096717|
|Publication number||09751382, 751382, US 6912424 B2, US 6912424B2, US-B2-6912424, US6912424 B2, US6912424B2|
|Inventors||Jon M. Bishay, Paul C. Leonard, Jay M. Miazga|
|Original Assignee||Meagan, Medical, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (89), Non-Patent Citations (78), Referenced by (6), Classifications (12), Legal Events (4)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation-in-part of: (1) U.S. application Ser. No. 09/452,477, titled “Percutaneous Electrical Therapy System with Electrode Entry Angle Control,” filed Dec. 1, 1999; now U.S. Pat. No. 6,622,051 and (2) U.S. application Ser. No. 09/666,931, titled “Method and Apparatus for Repositioning a Percutaneous Probe,” filed Sep. 21, 2000 now U.S. Pat. No. 6,529,776, both incorporated herein in their entireties by reference.
This invention relates generally to apparatuses and methods for coupling therapeutic and/or monitoring equipment to a patient.
Electrical therapy has long been used in medicine to treat pain and other conditions. For example, transcutaneous electrical nerve stimulation (TENS) systems deliver electrical energy through electrode patches placed on the surface of a patient's skin to treat pam in tissue beneath and around the location of the patches. However, the TENS systems may not adequately alleviate pain in certain circumstances.
More recently, a technique in which electrodes are placed through the patient's skin into the target tissue has been proposed. Percutaneous Neuromodulation Therapy (“PNT”) (also sometimes called Percutaneous Electrical Nerve Stimulation or “PENS”) using percutaneously placed electrodes achieves significantly better pain relief results than TENS treatments using skin surface electrodes. This therapy is described in Ghoname et al., “Percutaneous Electrical Nerve Stimulation for Low Back Pain,” JAMA 281:818-23 (1999); Ghoname et al., “The Effect of Stimulus Frequency on the Analgesic Response to Percutaneous Electrical Nerve Stimulation in Patients with Chronic Low Back Pain,” Anesth. Analg. 88:841-6 (1999); Ahmed et al., “Percutaneous Electrical Nerve Stimulation (PENS): A Complementary Therapy for the Management of Pain Secondary to Bony Metastasis,” Clinical Journal of Pain 14:320-3 (1998); and Ahmed et al., “Percutaneous Electrical Nerve Stimulation: An Alternative to Antiviral Drugs for Herpes Zoster,” Anesth. Analg. 87:911-4 (1998). The contents of these references are incorporated herein by reference.
Thus far, PNT practitioners have used percutaneously placed acupuncture needles attached to waveform generators via cables and alligator clips to deliver the therapy to the patient. One feature of conventional PNT systems is that they typically include a number of electrical cables that must be properly connected to the corresponding percutaneous electrodes to deliver effective electrical therapy. Accordingly, a drawback with these conventional systems is that it can be difficult (particularly for inexperienced practitioners) to connect each electrical cable to the proper corresponding electrode. This drawback is shared as well by other systems that require multiple connections to the patient. Such systems include electrical monitoring systems and drug delivery systems.
The invention is directed to apparatuses and methods for supporting therapeutic and/or diagnostic couplers for removable coupling to a recipient. An apparatus in accordance with one aspect of the invention can include a support member configured to rest on a body of the recipient proximate to a coupling region. The support member can include a first coupler location configured to removably carry a first coupler proximate to a first coupling position of the body of the recipient. The support member can further include a second coupler location configured to removably carry a second coupler proximate to a second coupling position of the body of the recipient. In one aspect of the invention, the support member can be spaced apart from the first and second coupling positions. In another aspect of the invention, the support member can be elongated along a support member axis and the first coupler location can be positioned closer than the second coupler location to the support member axis. In still another aspect of the invention, the first coupler location can be positioned closer than the second coupler location to the first coupling position. Accordingly, the apparatus can guide a practitioner to connect the couplers to the correct coupling position.
In another aspect of the invention, the support member can be flexible and resilient to conform to a surface of the body, and can be shaped to rest on at least one of a back, a neck, a head, and a leg of the recipient. The apparatus can further include a flexible link coupled between the first coupler and the support member. The link can remain connected between the first coupler and the support member when the first coupler is moved from an attached position to a detached position and then to a coupled position with the coupler coupled to the body of the recipient. The link can include an electrical cable configured to be coupled to a source of electrical pulses, an electrical cable configured to be coupled to a signal monitor, and/or a length of tubing configured to be coupled to a source of liquid medicament.
In yet another aspect of the invention, the first and second coupling positions can be two of a larger plurality of coupling positions and the first and second coupler locations can be two of a larger plurality of coupler locations. An outline of the coupling positions can define a first shape and an outline of the coupler locations can define a corresponding second shape at least generally similar to the first shape.
The invention is also directed toward a method for coupling therapy and/or monitoring equipment to a recipient. The method can include positioning a support member against a body of a recipient proximate to a coupling area, supporting a first coupler relative to the body at a first coupler location of the support member proximate to a first coupling position of the body, and supporting a second coupler relative to the body at a second coupler location of the support member proximate to a second coupling position of the body. In one aspect of the invention, the support member can be elongated along a support member axis and the first coupler location can be positioned closer than the second coupler location to the first coupling position and/or to the support member axis. In another aspect of the invention, the support member can be spaced apart from the first and second coupling positions. The method can further include removing the first coupler from the support member and coupling the first coupler to the body at the first coupling position, and removing the second coupler from the support member and coupling the second coupler to the body at the second coupling position.
Percutaneous electrical therapy systems, such as PNT systems, deliver electric current to a region of a patient's tissue through electrodes that pierce the skin covering the tissue. The electric current is generated by a control unit external to the patient and typically has particular waveform characteristics such as frequency, amplitude and pulse width. Depending on the treatment or therapy being delivered, there may be one electrode containing both a cathode and an anode or a plurality of electrodes with at least one serving as a cathode and at least one serving as an anode.
The electrode has a sharp point not only to facilitate insertion through the patient's skin but also to enhance local current density during treatment. The placement and location of the electrode point is therefore an important aspect of the therapy. The electrodes must also be properly coupled to the control unit to form a complete circuit for delivering therapeutic electric current to the patient.
Deployment of the electrode assembly can include the steps taken to place the electrode assembly in proper position and condition for use in electrical therapy.
The actuator 6 may have a limit stop 9 element cooperating with a limit stop area 8 of the housing 4 to limit distal motion of the actuator 6 and to control the depth of insertion of the sharp point 2 of the electrode 1. In one embodiment, for example, when the electrical therapy system is used to provide percutaneous neuromodulation therapy, the predetermined electrode depth is 3 cm. Other electrode depths may be used, of course, depending on the intended application and therapy.
After insertion, the housing 4 and the actuator 6 (which have heretofore acted as an electrode introducer) can be removed, as shown in FIG. 1D. The electrode 1 can be connected to a control unit 10 via a conductor or cable 16. For use with PNT, the control unit 10 can supply a current-regulated and current-balanced waveform with an amplitude of up to approximately 20 mA, a frequency between approximately 4 Hz and 50 Hz, and pulse width of between approximately 50 μsec and 1 msec. Other electrical waveforms having other parameters may be used, of course, depending on the therapy to be provided. Also, while
After completion of the electrical therapy, the electrode assembly can be undeployed. In an embodiment shown in
To begin deployment, a distal face 21 of the housing 18 is placed against the patient's skin 22, as shown in FIG. 2B. As with the previous embodiment, this action supports the housing 18 with respect to the patient's skin, thereby controlling the angle between the housing and the patient's skin. The sharp point 20 of electrode 12 is then inserted through an aperture 24 into the tissue underlying the patient's skin by moving an actuator 19 distally, as shown in FIG. 2C. As it moves, the actuator 19 (and therefore the electrode 12) is supported by the housing 18 to control the angle at which the electrode enters into the patient's tissue.
The actuator 19 may be part of the electrode assembly 13 or a separate component of the system. The actuator 19 may also have a limit stop element 23 that cooperates with a limit stop area 17 of housing 18 to limit distal movement of actuator 19, thereby controlling the depth of insertion of electrode 12. In one embodiment, for example, when the electrical stimulation system is used to provide percutaneous neuromodulation therapy, the predetermined electrode depth is approximately 3 cm, although other electrode depths may be used depending on the application. The control unit 10 may then provide the appropriate therapy to the patient through the electrode 12 and any other electrodes connected to it.
During undeployment, the actuator 19 can draw the electrode 12 back proximally into the housing 18. After the electrode 12 is removed from the patient's skin, the housing 18 of sharp point protection assembly 14 once again surrounds the sharp point 20 of the now uninserted electrode 12, as shown in
To use the percutaneous electrical therapy systems of
The actuator 36 fits within a housing portion 40 of base 32 in a slidable arrangement. A locking assembly can prevent relative movement between the actuator 36 and the housing 40 of the base 32. In one embodiment, the locking assembly of the actuator 36 has integrally-formed resilient detents 48 on its exterior cylindrical surface. In the undeployed state of electrode assembly 30, the detents 48 mate with corresponding openings 50 in the base 32 to hold the actuator 36 and the base 32 in place with respect to each other to prevent the electrode 34 from moving outside of the protective housing 40 of the base 32, thereby providing sharp point protection. In other embodiments, mechanisms other than the detent and opening arrangement may be used to hold the actuator and base in place.
In one embodiment, the electrode 34 can include a 3-cm long 32-gauge stainless steel needle. Other sizes and materials may be used for the electrode 34, of course, without departing from the scope of the invention. The actuator 36 can be formed from HDPE as well, although other suitable materials may be used.
The electrode 34 can have a larger-diameter handle 52 at its proximal end. The handle 52 can fit within a channel 54 formed within the actuator 36. The channel 54 can have a narrow opening 56 at its distal end, with a diameter slightly larger than the diameter of electrode 34 but narrower than the diameter of handle 52 to hold electrode 34 in place within the actuator 36 after initial manufacture and assembly. In the undeployed state shown in
To deploy one or more electrode assemblies on a patient in order to provide electrical stimulation therapy (such as PNT), the distal surface 46 of the flange portion 44 of the base 32 can be mounted on the desired site on the patient's skin, preferably with a compressible adhesive pad (not shown) surrounding a ring 43 extending downward from surface 46 around an aperture 41 formed at the distal end of channel 42, although other means of attaching base 32 to the patient may be used as appropriate. This action aligns the base 32 with respect to the patient's skin. The flange portion 44 of the base 32 provides extra stability for the electrode assembly during electrode insertion and use.
A coupler or actuator tool 60 can be used to both insert the electrode and connect the electrode electrically with a control unit 62. The coupler 60 and the electrode assembly 30 can also interact to provide the sharp point protection assembly of this embodiment. When the distal end of the coupler 60 is placed against the proximal ends of the base 32 and the actuator 36, the exposed proximal end 64 of the electrode handle 52 makes electrical contact with a contact surface 66 within the coupler 60. The contact surface 66, in turn, can be electrically connected to the control unit 62 via a cable or other conductor 68.
The coupler 60 can have two oppositely disposed pegs 70 extending outwardly from the distal portion of its cylindrically surface. The pegs 70 can mate with two corresponding slots 72 in the actuator 36 and with two corresponding grooves 74 in the base 32. The second of the two slots 72 and the second of the two grooves 74 are each opposite the slot 72 and groove 74, respectively, shown in
The coupler 60 can be rotated clockwise (looking down on the assembly), after the pegs 70 reach the end of the longitudinal portions 76 and 78. Accordingly, the pegs 70 move into short circumferential portions 80 and 82, respectively, of the slots 72 and the grooves 74. The length of the circumferential portions 80 of the slots 72 is less than the length of the circumferential portions 82 of the grooves 74. Continued movement of the pegs 70 along the circumferential portions 82 will therefore move the pegs 70 against the ends 81 of the circumferential slots 80. Further clockwise rotation of the coupler 60 will cause the actuator 36 to rotate clockwise as well, thereby moving the detents 48 out of the openings 50 and allowing the electrode 34 and the actuator 36 to move with respect to base 32.
Second longitudinal portions 84 of the grooves 74 can be formed in base 32 at the end of circumferential portions 82. Movement of the pegs 70 distally along the second longitudinal portions 84 pushes the pegs 70 against the distal edges of the circumferential slot portions 80, thereby moving the actuator 36 and the electrode 34 in a controlled fashion distally toward the patient's skin 22.
As it moves, the electrode 34 passes through the channel 42, and the sharp point of electrode 34 moves out through aperture 41. The channel 42 and the actuator 36 provide axial support to the electrode 34 during this forward movement and also, along with the support provided by the flange 44, provide entry angle guidance to the electrode 34. In addition, downward pressure on the patient's skin during electrode deployment can compress the compressible adhesive pad and press the ring 43 against the patient's skin 22, which helps ease electrode entry through the skin and also lessens the insertion pain experienced by the patient.
The alignment of the base 32 with respect to the patient's skin and the controlled movement of the actuator 36 and the electrode 34 within the base 32 can control the angle at which the electrode enters the tissue underlying the patient's skin. Distal movement of the electrode 34 and its actuator within the base 32 can continue until a distal surface 86 of a cylindrical cap portion 92 of the coupler 60 meets an annular surface 88 of housing 40. At this point, the sharp point 38 of the electrode 34 has extended a predetermined depth into the tissue underlying the patient's skin. In one embodiment, this predetermined depth is approximately 3 cm, and the depth can have other values depending on the treatment to be performed.
The electrode assembly 30 can also include a deployed electrode holding mechanism. In one aspect of this embodiment, an interference fit between the inner surface of channel 42 and the outer surface 55 of channel 52 performs this function.
Electrical stimulation treatment may begin once the electrodes have been deployed and inserted. The control unit 62 can supply stimulation current to the electrodes, e.g., in the manner described in the Ghoname et al articles. The electrical waveform provided by the control unit depends on the application. For example, in one embodiment, the control unit 62 can provide a current-regulated and current-balanced waveform with an amplitude of up to approximately 20 mA, frequency between approximately 4 Hz and 50 Hz, and pulse width of between approximately 50 μsec and 1 msec. In other embodiments, the control unit 62 can provide electrical current at other frequencies.
The interaction of the coupler 60 and the base 32 can provide stability to the electrode 34 and its electrical connection to the control unit during treatment by holding the electrode in place, by providing strain relief for tugging forces on the cable 68, and by providing a robust mechanical connection. It should also be noted that in one aspect of these embodiments, the sharp point of the electrode 34 is not exposed to the operator or to any other bystander at any point during deployment and use of the electrode assembly.
After treatment has been completed, the electrode may be removed from the patient. To do so, the coupler 60 can be moved proximally away from the patient. As the pegs 70 move proximally along the longitudinal portions 84 of the grooves 74, the pegs 70 push against the proximal edges of the actuator's circumferential slot portions 80, thereby moving the actuator 36 and the electrode 34 proximally as well. When the pegs 70 reach the proximal end of the longitudinal groove portions 84, the sharp end 38 of the electrode 34 is out of the patient and safely inside the housing 40 of the base 32. Counterclockwise movement of the coupler 60 moves the pegs 70 along the circumferential portions 80 and 82 of the slot 72 and the groove 74, respectively. Because the circumferential portion 80 is shorter than the circumferential portion 82, this counterclockwise movement will turn the actuator 36 counterclockwise.
At the limit of the counterclockwise movement, the detents 48 move back into the openings 50 to prevent further movement of the electrode and the actuator with respect to the base 32. Further distal movement of the coupler 60 moves the pegs 70 distally along the longitudinal portions 76 and 78 of the slot 72 and the groove 74, respectively, to disconnect the coupler 60 from the electrode assembly 30. The base 32 can then be removed from the patient.
In another aspect of this embodiment, an arrangement of the engagement members 65 on the support member 63 can correspond to an arrangement of the electrode assemblies 30 a-j on the patient's back. For example, when the electrode assemblies 30 a-j are connected to the patient at ten sites arranged in two rows on each side of the patient's spine, the engagement members 65 can be arranged in two rows, one on each side of a central axis 67 (
Once each electrode assembly 30 has been actuated by its respective coupler 60 to insert an electrode into the patient's tissue (as shown in FIG. 12), the control unit 62 provides electrical signals to treat the patient. As described above, half the electrodes (e.g., assemblies 30 b, 30 d, 30 g, 30 h and 30 i) can serve as anodes, and the other half as cathodes. In one embodiment, the control unit 62 can provide a current-regulated and current-balanced waveform with an amplitude of up to approximately 20 mA, frequency between approximately 4 Hz and 50 Hz, and pulse width of between approximately 50 μsec and 1 msec. to treat the patient's low back pain using PNT.
Twelve electrodes 102 are disposed within a magazine 103 rotatably mounted within a housing 104. In one embodiment, the housing 104 is a two-part injection molded polystyrene assembly. As shown in
The magazine 103 can have twelve electrode chambers 115 arranged radially about the hub 105. When the introducer 100 is completely full, each chamber 115 contains one electrode 102. The diameter of an upper portion 118 of the chamber 115 is sized to form an interference fit with the wider portions 112 and 114 of electrode handle portion 107 of electrode 102. A lower wide portion 114 of electrode 102 can be formed from a compressible material. The diameter of a lower portion 119 of the chamber 115 is slightly larger so that there is no interference fit between the lower portion 119 and the electrode handle 107, for reasons explained below. Each time the leaf spring 106 is within a groove 108, the opening 106 of a magazine chamber 115 is lined up with the aperture 117 of the introducer 100, as shown in
A slide member 109 is disposed on a rail 110 formed in the housing 104. Extending longitudinally downwardly from the slide member 109 is a drive rod 111, and extending longitudinally upwardly from the slide member 109 is a gear rack 120. The teeth of the gear rack 120 cooperate with the teeth on a rotational gear 122 mounted about a shaft 124 extending into a shaft mount 126 formed in the housing 104. A second set of teeth are mounted on a smaller diameter rotational gear 128 (shown more clearly in
The teeth of the smaller diameter gear 128 mesh with the teeth of a second gear rack 130 extending from a longitudinally-movable actuator 132. A spring 134 mounted between the actuator 132 and a spring platform 136 biases the actuator 132 away from the housing 104.
To deploy the electrode assembly of this embodiment, a flexible and compressible annular patch 140 is placed on the patient's skin at the desired site, preferably with an adhesive (not shown). For example, to treat low back pain using PNT, the arrangement or montage shown in
As shown in
After the patch 140 is in place, the distal end of the introducer 100 is placed against the patch 140 so that the introducer aperture 117 surrounds the upwardly extending portion of rigid patch member 141, as shown in FIG. 18. This interaction aligns the opening 116 of one of the introducer's magazine chambers 115 with the opening 142 of the rigid member 141 and helps control the electrode's angle of entry, as shown in FIG. 19. Downward pressure on the introducer 100 compresses the patch 140, thereby causing the upper surface of the rigid member 141 to engage a lower surface of the magazine 103, and pressing the rigid member 141 downward into the patient's skin 22. This pressure on the patient's skin around the insertion site can reduce the pain caused by inserting the electrode.
Depressing the actuator 132 moves the gear rack 130 distally, which causes the gears 128 and 122 to rotate. Because the diameter and tooth count of the gear 128 differ from the diameter and tooth count the gear 122, the gear rack 120 moves longitudinally a much greater distance than the corresponding longitudinal movement of the gear rack 130. This feature enables the electrode to be inserted its required distance into the patient's skin using only a comparatively small movement of the operator's thumb. Distal movement of the gear rack 120 is guided by the movement of the slide member 109 along the rail 110.
As the slide member 109 moves distally, the drive rod 111 moves into a magazine chamber 115 until the distal end of the drive rod 111 engages the top surface of the electrode's handle portion 107. As shown in
When the top portion 112 of the electrode handle portion 107 leaves the smaller diameter portion 118 of the magazine chamber 115, it enters the larger diameter portion 119 of the chamber 115. At this point (shown in FIG. 21), because the diameter of chamber portion 119 is wider than the diameter of the electrode handle 107, the electrode is no longer attached to the introducer 100.
Continued downward movement of the actuator 132 and the drive rod 111 pushes the lower larger diameter portion 114 of the electrode handle 107 through the smaller diameter portion 142 of rigid member 141 by compressing the handle portion 114. Further downward movement pushes the handle portion 114 into the larger diameter portion 144 of the rigid member 141 so that the rigid member's smaller diameter portion lies between the larger diameter portions 112 and 114 of the electrode handle 107. This interaction holds the electrode in place in the patient's tissue and helps provide depth control for electrode insertion. In this embodiment, the preferred depth of the electrode's sharp point 108 is approximately 3 cm, although the electrode may be inserted to other depths depending on the treatment to be performed. The slider member 109 also acts as a limit stop at this point when it engages the limit stop area 145 of housing 104, thereby also controlling electrode insertion depth.
The magazine 103 can be rotated to a new insertion position and placed against an empty patch 140 after insertion of each electrode until all electrodes have been deployed and inserted. A suitable electrical connector 148, such as an alligator clip, can be electrically connected to electrode 102 through an aperture (not shown) formed in the upper larger diameter portion 112 of electrode handle 107 to provide electrical communication between a control unit 150 and electrode 102 via a cable or other conductor 149, as shown in FIG. 22. The patch 140 can provide strain relief for the electrode 102 by preventing tugging forces on the cable 149 from dislodging the electrode from the patient, thereby helping keep the electrode in place. In one aspect of this embodiment, the sharp point of the electrode is not exposed to the operator or bystander at any point during the electrode deployment, insertion and electrical therapy treatment processes.
The control unit 150 supplies stimulation current to the electrodes, e.g., in the manner described in the Ghoname et al. articles. Once again, the electrical waveform provided by the control unit depends on the application. For example, in an embodiment of a system providing percutaneous neuromodulation therapy, the control unit 150 can provide a current-regulated and current-balanced waveform with an amplitude of up to approximately 20 mA, frequency between approximately 4 Hz and 50 Hz, and pulse width of between approximately 50 μsec and 1 msec.
In an alternative embodiment, the lower wide portion of the electrode handle can be formed from a rigid material and can have rounded camming edges. The central annulus of patch 140 in this alternative embodiment is either compressible or has a resilient camming opening under the camming action of the electrode handle.
When the couplers 260 are generally similar to the couplers 60 described above with reference to
The coupler support 200 can include links 250 between the support member 220 and each coupler 260. In one aspect of this embodiment, the links 250 can include electrical cables to transmit electrical signals to the couplers 260 and to the patient or recipient to whom the couplers 260 are attached. In other embodiments, the links 250 can have other configurations, as described below with reference to
When the links 250 include electrical cables, each link 250 can enter the support member 220 at an entry attachment point 223. The links 250 can then pass through a cable channel 212 of the support member 220 and exit the support member 220 at an exit attachment point 224. The links 250 can be bundled together to form a bundled link 251 that can be attached to an electrical connector 252 for coupling to a source of electrical potential.
In one embodiment, the support member 220 can include an upper portion 210 bonded to a lower portion 211. The upper portion 210 can include the cable channel 212 and the engagement members 240. The support member 220 can be formed by molding the upper portion 210, inverting the upper portion 210, and laying a cable harness (which includes the bundled link 251 and the individual links 250) into the cable channel 212. The lower portion 211 can be attached to the upper portion 210 (for example, in an overmold process) to fix the harness into the support member 220. In other embodiments, the coupler support 200 can be formed with other techniques. In any of these embodiments, the support member 220 can include a flexible, soft durometer, bio-compatible, thermoplastic elastomeric material, such as Sanoprene®, available from Advanced Elastomeric Systems of Akron, Ohio. Accordingly, the support member 220 can conform to the shape of the recipient's body, as described below with reference to FIG. 24.
In a further aspect of this embodiment, the shape of the support member 220 and the positions of the engaging members on the support member 220 can be configured to aid the practitioner in connecting each coupler 260 to the correct corresponding coupling site on the recipient's body. For example, when the coupler support 200 is configured to administer electrical therapy to the recipient's back, the support member 220 can have an axial elongated portion 221 aligned with a central axis 270. The support member 220 can further include two transverse elongated portions 222 (shown as a first transverse elongated portion 222 a and second transverse elongated portion 222 b) arranged transverse to the central axis 270. In one aspect of this embodiment, the coupler support 200 generally and the elongated portions 221, 222 in particular can be configured to be spaced apart from corresponding coupling sites on the recipient's back, so as not to interfere with the operation of attaching the couplers 260 to the recipient. For example, in one embodiment, the axial elongated portion 221 can have a length of about 11 inches ±0.25 inch (measured from the exit attachment point 224). The transverse elongated portions 222 a, 222 b can have lengths of about 6.8 inches and about 7.5 inches, respectively, ±0.25 inch. In other embodiments, the elongated portions 221, 222 can have other dimensions. In any of these embodiments, each coupler 260 can be positioned proximate to its corresponding coupling site to aid the practitioner in connecting the couplers with the appropriate coupling site, as described below with reference to FIG. 24.
The coupling area 280 includes a plurality of coupling positions or sites 281 (shown as 281 a-j) at which a corresponding plurality of electrode assemblies 230 (shown as 230 a-j) are attached. In one embodiment, the electrode assemblies 230 are arranged in cathode/anode pairs with five circuits formed by electrode assembly pairs 230 a and 230 b; 230 c and 230 d; 230 e and 230 f, 230 g and 230 h; and 230 i and 230 j. Once the coupler support 200 is in position on the recipient's back, each engagement member 240 (shown as 240 a-j) is positioned proximate to its corresponding electrode assembly 230 a-j. For example, those engagement members 240 that are to be coupled with electrode assemblies 230 close to the body longitudinal axis 271 are positioned close to the central axis 270 of the coupler support 200. Those engagement members 240 that are to be coupled with electrode assemblies 230 further away from body longitudinal axis 271 are positioned further away from the central axis 270 of the coupler support 200. Accordingly, many of the couplers 260 are positioned closer to the one corresponding electrode assembly 230 to which that coupler 260 is to be connected than to any other electrode assembly. As a result, practitioners will be less likely to link the couplers 260 to the incorrect electrode assembly 230.
In another aspect of this embodiment, the coupler support 200 can include other features to further aid the practitioner in attaching the couplers 260 to the correct coupling site 281. For example, the engagement member 240 a can be can be offset to the right side of the central axis 270 and the engagement member 240 b can be offset to the left side of the central axis 270 so that the practitioner will be more likely to connect the corresponding couplers 260 a, 260 b (
In one aspect of the embodiments described above with reference to
A feature of embodiments of the coupler support arrangements described above with reference to FIGS. 11 and 23-30 is that the supports are configured to position the couplers proximate to the appropriate coupling location. Accordingly, practitioners, including relatively inexperienced practitioners, can be less likely to connect the couplers to an incorrect coupling location. An advantage of this arrangement is that the couplers can provide more reliable and/or more efficacious therapy and/or diagnostic information. A further advantage is that the practitioner can more quickly connect the couplers to the recipient, increasing the efficiency with which the practitioner can provide therapy and/or diagnostic information.
Still a further advantage of embodiments of the coupler support described above is that a single support can accommodate a wide variety of applications. For example, a single support can be used with recipients ranging in height from about 4.5 feet to about 6.5 feet, as discussed above. A single coupler support can also be used with recipients having a wide variety of body shapes. Still further, a single coupler support can be positioned on recipients having a variety of postures. For example, a single coupler support can rest on the recipient's back whether the recipient is prone, leaning over, or partially upright, while still allowing the couplers to be connected to the appropriate coupling locations.
From the foregoing, it will be appreciated that, although specific embodiments of the invention have been described herein for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the invention. For example, the couplers can be connected directly to the recipient rather than being connected to an intermediate device such as an electrode (i.e., the electrode can be integrated with the coupler). The coupler locations of the support member can include posts or columns, apertures, or any other feature that removably carries the couplers. Accordingly, the invention is not limited except as by the appended claims.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US3030959||Sep 4, 1959||Apr 24, 1962||Praemeta||Surgical lancet for blood sampling|
|US3090151||Feb 14, 1958||May 21, 1963||Stewart Trigg||Underwater spear gun|
|US3208452||Sep 8, 1960||Sep 28, 1965||Panray Parlam Corp||Surface treating device|
|US3938526||May 20, 1974||Feb 17, 1976||Anderson Weston A||Electrical acupuncture needle heater|
|US3943935||Sep 7, 1973||Mar 16, 1976||Cameron Robert C||Disposable earlobe piercing apparatus|
|US3983881||May 21, 1975||Oct 5, 1976||Telectronics Pty. Limited||Muscle stimulator|
|US4139011||Dec 17, 1976||Feb 13, 1979||Benoit Jean L P M||Device for driving a needle into a patient|
|US4153059||Oct 25, 1977||May 8, 1979||Minnesota Mining And Manufacturing Company||Urinary incontinence stimulator system|
|US4207903||Apr 28, 1978||Jun 17, 1980||Medtronic, Inc.||Device for screwing body tissue electrode into body tissue|
|US4256116||Jul 3, 1978||Mar 17, 1981||Technion Research And Development Foundation, Limited||Transcutaneous pain reliever|
|US4262672||Dec 28, 1978||Apr 21, 1981||Horst Kief||Acupuncture instrument|
|US4281659||Mar 12, 1979||Aug 4, 1981||Roche Medical Electronics Inc.||Applying and securing percutaneous or transcutaneous probes to the skin especially for fetal monitoring|
|US4284856||Sep 24, 1979||Aug 18, 1981||Hochmair Ingeborg||Multi-frequency system and method for enhancing auditory stimulation and the like|
|US4381012 *||Sep 24, 1980||Apr 26, 1983||Wallant International Trade, Inc.||Electrode placement device|
|US4408617||Jan 19, 1981||Oct 11, 1983||Deloffre Auguste||Apparatus for detecting the acupuncture points on a patient and for applying electrical stimulating signals to the detected points|
|US4431000||May 23, 1980||Feb 14, 1984||Gatron Corporation||Transcutaneous nerve stimulator with pseusorandom pulse generator|
|US4437467||Dec 11, 1981||Mar 20, 1984||American Home Products Corporation||Apparatus for monitoring fetal heartbeat and the like|
|US4512351||Nov 19, 1982||Apr 23, 1985||Cordis Corporation||Percutaneous lead introducing system and method|
|US4541432||Dec 17, 1982||Sep 17, 1985||Neurotronic Ltee||Electric nerve stimulator device|
|US4556064||Jan 25, 1983||Dec 3, 1985||Bruce Pomeranz||Electrotherapy acupuncture apparatus and method|
|US4583549||May 30, 1984||Apr 22, 1986||Samir Manoli||ECG electrode pad|
|US4685466||Jan 28, 1986||Aug 11, 1987||Rau Guenter||Measuring sensor for the non-invasive detection of electro-physiological quantities|
|US4686996||Aug 1, 1986||Aug 18, 1987||Paul Ulbrich||Electrode assembly for sensing heart activity|
|US4712558||Mar 12, 1985||Dec 15, 1987||Bio Medical Research Ltd.||Electrical stimulation of muscle|
|US4765310||Oct 29, 1986||Aug 23, 1988||Dynatens Research Corporation||Electrical and magnetic pain treatment device|
|US4895154||Feb 19, 1988||Jan 23, 1990||Staodynamics, Inc.||Electronic stimulating device for enhanced healing of soft tissue wounds|
|US4934371||May 12, 1989||Jun 19, 1990||American Home Products Corporation||Fetal electrode product|
|US4949734||Aug 25, 1988||Aug 21, 1990||Gerald Bernstein||Shield for electrosurgical device|
|US4953564||Aug 23, 1989||Sep 4, 1990||Medtronic, Inc.||Screw-in drug eluting lead|
|US4979508||Apr 11, 1987||Dec 25, 1990||Beck Stephen C||Apparatus for generating phosphenes|
|US5012811||Dec 20, 1988||May 7, 1991||American Home Products Corporation||Fetal electrode product with protective cap|
|US5033474 *||Jan 5, 1990||Jul 23, 1991||Buddy Systems, Inc.||ECG cable storage means in a personal health monitor|
|US5036850||Aug 25, 1989||Aug 6, 1991||Staodyn, Inc.||Biphasic pulse output stage for electronic stimulating device|
|US5054486||May 31, 1990||Oct 8, 1991||Mamoru Yamada||Remedial techniques for the treatment of painful disorders such as intervertebral disc hernia and the like|
|US5094242||Dec 9, 1988||Mar 10, 1992||Regents Of The University Of California||Implantable nerve stimulation device|
|US5117826||May 2, 1991||Jun 2, 1992||Staodyn, Inc.||Combined nerve fiber and body tissue stimulation apparatus and method|
|US5211175||Mar 3, 1992||May 18, 1993||Regents Of The University Of California||Method for implanting electra-acupuncture needle|
|US5246014||Nov 8, 1991||Sep 21, 1993||Medtronic, Inc.||Implantable lead system|
|US5255691||Nov 13, 1991||Oct 26, 1993||Medtronic, Inc.||Percutaneous epidural lead introducing system and method|
|US5269304||Sep 4, 1991||Dec 14, 1993||Tony Matthews||Electro-therapy apparatus|
|US5281218||Jun 5, 1992||Jan 25, 1994||Cardiac Pathways Corporation||Catheter having needle electrode for radiofrequency ablation|
|US5332401||Oct 31, 1990||Jul 26, 1994||Capel Ifor Donald||Apparatus and method for transcranial electrotheraphy|
|US5417719||Aug 25, 1993||May 23, 1995||Medtronic, Inc.||Method of using a spinal cord stimulation lead|
|US5423314||Aug 2, 1993||Jun 13, 1995||Hewlett Packard Company||Introduction apparatus for a fetal scalp electrode|
|US5439440||Apr 1, 1993||Aug 8, 1995||Genetronics, Inc.||Electroporation system with voltage control feedback for clinical applications|
|US5449378||Apr 5, 1993||Sep 12, 1995||Schouenborg; Jens||Method and apparatus for the electric stimulation of skin receptors|
|US5593429||Jun 28, 1994||Jan 14, 1997||Cadwell Industries, Inc.||Needle electrode with depth of penetration limiter|
|US5649936||Sep 19, 1995||Jul 22, 1997||Real; Douglas D.||Stereotactic guide apparatus for use with neurosurgical headframe|
|US5674267||Mar 24, 1994||Oct 7, 1997||Centre National De La Recherche Scientifique||Electric pulse applicator using pairs of needle electrodes for the treatment of biological tissue|
|US5682233||Nov 20, 1996||Oct 28, 1997||Integ, Inc.||Interstitial fluid sampler|
|US5702359||Jun 6, 1995||Dec 30, 1997||Genetronics, Inc.||Needle electrodes for mediated delivery of drugs and genes|
|US5810762||Apr 10, 1995||Sep 22, 1998||Genetronics, Inc.||Electroporation system with voltage control feedback for clinical applications|
|US5851223||Feb 16, 1995||Dec 22, 1998||Medi Consultants, Inc.||Combination non-intrusive analgesic neuroaugmentive system and method triple-modulated gigatens with optional bipolar spike|
|US5861015||May 5, 1997||Jan 19, 1999||Benja-Athon; Anuthep||Modulation of the nervous system for treatment of pain and related disorders|
|US5873849||Apr 24, 1997||Feb 23, 1999||Ichor Medical Systems, Inc.||Electrodes and electrode arrays for generating electroporation inducing electrical fields|
|US5928144||Dec 6, 1996||Jul 27, 1999||Real; Douglas D.||Needle electrode|
|US5941845||Aug 5, 1997||Aug 24, 1999||Irvine Biomedical, Inc.||Catheter having multiple-needle electrode and methods thereof|
|US5948008||Dec 28, 1995||Sep 7, 1999||S.L.T. Japan Co., Ltd.||Apparatus for treatment of lumbar disc herniation|
|US5968011||Jun 20, 1997||Oct 19, 1999||Maersk Medical A/S||Subcutaneous injection set|
|US5968063||May 14, 1997||Oct 19, 1999||Jennifer Chu||Intramuscular stimulation therapy facilitating device and method|
|US6009347||Jan 27, 1998||Dec 28, 1999||Genetronics, Inc.||Electroporation apparatus with connective electrode template|
|US6032064||Oct 11, 1996||Feb 29, 2000||Aspect Medical Systems, Inc.||Electrode array system for measuring electrophysiological signals|
|US6035236||Jul 13, 1998||Mar 7, 2000||Bionergy Therapeutics, Inc.||Methods and apparatus for electrical microcurrent stimulation therapy|
|US6050992||May 19, 1997||Apr 18, 2000||Radiotherapeutics Corporation||Apparatus and method for treating tissue with multiple electrodes|
|US6068650||Nov 9, 1998||May 30, 2000||Gentronics Inc.||Method of Selectively applying needle array configurations|
|US6117077 *||Jan 22, 1999||Sep 12, 2000||Del Mar Medical Systems, Llc||Long-term, ambulatory physiological recorder|
|US6122547||Oct 20, 1998||Sep 19, 2000||Benja-Athon; Anuthep||Consolidated electrical-lead acupuncture needle|
|US6208893||Jan 21, 1999||Mar 27, 2001||Genetronics, Inc.||Electroporation apparatus with connective electrode template|
|US6219569||Jun 14, 1999||Apr 17, 2001||Unilead International Inc.||Electrodeless electro-dermal device|
|US6269270||Oct 26, 1998||Jul 31, 2001||Birinder Bob Boveja||Apparatus and method for adjunct (add-on) therapy of Dementia and Alzheimer's disease utilizing an implantable lead and external stimulator|
|US6304785||Oct 27, 1999||Oct 16, 2001||Huntington Medical Research Institute||Electrode insertion tool|
|US6341237||Oct 25, 1999||Jan 22, 2002||Arthur F. Hurtado||Device for administrating electro-muscle stimulation and method of use|
|US6355021||Jul 14, 1998||Mar 12, 2002||Maersk Medical A/S||Medical puncturing device|
|US6493592||Dec 1, 1999||Dec 10, 2002||Vertis Neuroscience, Inc.||Percutaneous electrical therapy system with electrode position maintenance|
|US6516226||Dec 1, 1999||Feb 4, 2003||Vertis Neuroscience, Inc.||Percutaneous electrical therapy system for minimizing electrode insertion discomfort|
|US6522927||Dec 1, 1999||Feb 18, 2003||Vertis Neuroscience, Inc.||Electrode assembly for a percutaneous electrical therapy system|
|US6539264||Dec 1, 1999||Mar 25, 2003||Vertis Neuroscience, Inc.||Percutaneous electrical therapy system with sharp point protection|
|US6549797||Dec 1, 1999||Apr 15, 2003||Vertis Neuroscience, Inc.||Electrode remover for a percutaneous electrical therapy system|
|US6549810||Dec 1, 1999||Apr 15, 2003||Vertis Neuroscience, Inc.||Percutaneous electrical therapy system with electrode depth control|
|US6556869||Dec 1, 1999||Apr 29, 2003||Vertis Neuroscience, Inc.||Electrode introducer for a percutaneous electrical therapy system|
|US6560491||Dec 1, 1999||May 6, 2003||Vertis Neuroscience, Inc.||Percutaneous electrical therapy system providing electrode axial support|
|USD297047||Dec 1, 1986||Aug 2, 1988||Sensor support plate for use with an external medical monitor device|
|USD318330||Oct 15, 1987||Jul 16, 1991||Unipolar spiral coil electrode for monitoring the electrical activity of the brain|
|USD357069||Aug 25, 1993||Apr 4, 1995||Quinton Instrument Company||Medical electrode|
|USD443063||Aug 25, 2000||May 29, 2001||Nexan Limited||Chest multisensor array|
|FR2500309A3||Title not available|
|FR2500745A1||Title not available|
|GB2163355A||Title not available|
|WO2001039829A1||Nov 30, 2000||Jun 7, 2001||Vertis Neuroscience Inc||Percutaneous electrical therapy system and electrode|
|1||Ahmed H. et al. "Percutaneous Electrical Nerve Stimulation (PENS): A Complementary Therapy for the Management of Paln Secondary to Bony Metastasis", The Clinical Journal of Paln (Dec. 1998) vol. 14, No. 4, pp. 320-323, Lippincott Williams & Wilkins, Philadelphia.|
|2||Ahmed H. et al. "Percutaneous Electrical Nerve Stimulation: An Alternative to Antiviral Drugs for Acute Herpes Zoster," Anesthesia & Analgesia (Oct. 1998) 87: 911-4.|
|3||Almay, B.G.L. et al., "Long-Term High Frequency Transcutaneous Electrical Nerve Stimulation (hi-TNS) in Chronic Pain. Clinical Response and Effects on CSF Endorphins, Monoamine Metabolites, Substance P-Like Immunoreactivity (SPLI) and Pain Measures," Journal of Psychosomatic Research, (1985) vol. 29, No. 3, pp. 247-257, Pergamon Press Ltd. Great Britain.|
|4||Association for Advancement of Medical Instrumentation, "Implantable Peripheral Nerve Stimulators," American National Standard, ANSI/AAMI NS15-1995 pp. 1-8 NS15-1995 pp. 1-8.|
|5||Baker, L. L., et al. "Effects of Waveform on Comfort during Neuromuscular Electrical Stimulation," Clinical Orthopaedics and Related Research, Aug. 1998, No. 223, pp. 75-85.|
|6||Ballegaard, S. et al. "Acupuncture and Transcutaneous Electric Nerve Stimulation in the Treatment of Pain Associated with Chronic Pancreatitis. A Randomized Study", Scand. J. Gastroenterol. (Jun. 1985) 20: 1249-54.|
|7||Balogun, J. et al. "The effects of acupunture, electroneedling and transcutaneous electrical stimulation therapies on peripheral haemodynamic functioning", Disability and Rehabilitation (Feb. 1998) vol. 20, No. 2, pp, 41-48, Taylor & Francis Ltd.|
|8||Balogun, J., "Effects of Ramp Time on Sensory, Motor and Tolerance Thresholds during Exogenous Electrical Stimulation," The Journal of Sports Medicine and Physical Fitness, (Dec. 1991) vol. 31, No. 4, pp. 521-526.|
|9||BD Microtainer Brand Safety Flow Lancet-Product No. 366356. BD catalog 1997-2000, http://catalog.bd.com/sctipts/OBDsheet.exe?FNC=productlist Alistproducts. html 3 66356 (Aug. 2001), 3 pages.|
|10||BD Safety Products. BD Vacutainer Safety-Lok Blood Collection Set; BD Vacutainer SafetyGlide Blood Collection Assembly and BD Vacutainer Eclipse Blood Collection Needle, 1 page.|
|11||BD Vacutainer SafetyGlide Blood Collection Assembly. Quick Reference Card (Oct. 1999), 1 page.|
|12||Brull, S. J., et al., "Pulse Width, Stimulus Intensity, Electrode Placement, and Polarity during Assessment of Neuromuscular Block," Anesthesiology, (Oct. 1995) V. 83, No. 4, pp. 702-709, Lippincott-Raven Publishers.|
|13||Bushnell, M. C. et al. "Electrical stimulation of peripheral and central pathways for the relief of musculoskeletal pain", Can. J. Physiol. Pharmacol. (May 1991) 69: 697703.|
|14||Carroll, D. et al., "Randomization is important in Studies with Pain Outcomes; Systematic Review of Transcutaneous Electrical Nerve Stimulation in Acute Postoperative Pain," British Journal of Anesthesiology, (1996) vol. 77, pp. 798-803.|
|15||Cassuto, J. et al., "The Use of Modulated Energy Carried on a High Frequency Wave for the Relief of Intractable Pain," International Journal of Clinical Pharm.Research (1993) XI II (4) pp. 239-241.|
|16||Cheng R. et al. "Electroacupunture elevates blood cortisol levels in naive horses; sham treatment has no effect", Intern. J. Neuroscience (Feb. 1980) vol. 10, pp. 95-97, Gordon and Breach Science Publishers, Inc., Great Britain.|
|17||Cheng R. S. S., Pomeranz, B. "Electrotherapy of Chronic Musculoskeletal Pain: Comparison of Electroacupuncture and Acupuncture-Like Transcutaneous Electrical Nerve Stimulation", The Clinical Journal of Pain (1987) vol. 2, No. 3, pp. 143-149, Raven Press, New York.|
|18||Cheng R., Pomeranz, B. "Electroacupunture analgesia could be mediated by at least two pain-relieving mechanisms; endorphin and non-endorphin systems", Life Sciences (Dec. 1979) 25: 1957-62, Pergamon Press Ltd.|
|19||Cramp, A.F.L. et al.,"The Effect of High- and Low-Frequency Transcutaneous Electrical Nerve Stimulation Upon Cutaneous Blood Flow and Skin Temperature in Healthy Subjects," Clinical Physiology 20, (2000) 2, pp. 150-157, Blackwell Science Ltd.|
|20||Empi Eclipse+ Dual Channel Transcutaneous Electrical Nerve Stimulator User's Manual, Empi, Inc. (Sep. 1998), US patent #D282,968, 31 pages.|
|21||Empi EPIX VT Dual Channel Transcutaneous Electrical Nerve Stimulator Instruction Manual, Empi, Inc. (1997) 22 pages.|
|22||Empi EPIX XL TENS Instruction Manual, Empi, Inc. (Sep. 1998) U.S. patent No. D319,881, 22 pages.|
|23||Empi, Our Products: Electrotherapy for Rehabilitation, http://www.empi.com/b/b2.htm, (Mar. 2001), 8 pages.|
|24||Foster, N.E., et al., "Manipulation of Transcutaneous Electrical Nerve Stimulation Variables Has No Effect on Two Models of Experimental Pain in Humans," The Clinical Journal of Pain, (1996) 12; pp. 301-310, Lippincott-Raven Publishers, Philadelphia.|
|25||Gadsby, G. et al. "Nerve stimulation for low back pain-a review," Nursing Standard (Jul. 1997) vol. 11, No. 43, pp. 32-33.|
|26||Galleti, S.P., et al., "Highlights in the Subject of Low Frequency-High Intensity TENS," Minerva Stomatologica (Italy) (Sep. 1995), 44, pp. 421-429.|
|27||Ghoname, E. et al. "Does the Stimulus Frequency Affect the Analgesic Response to Electrical Stimulation?" Anesthesia & Analgesia (Nov. 1999) 88: S210, Lippincott Williams & Wilkins.|
|28||Ghoname, E. et al. "Percutaneous Electrical Nerve Stimulation for Low Back Pain", JAMA (Mar. 1999) vol. 281, No. 9, pp. 818-823.|
|29||Ghoname, E. et al. "Percutaneous electrical nerve stimulation: an alternative to TENS in the management of sciatica", Pain (Nov. 1999) 83: 193-9, Elsevier Science B.V.|
|30||Ghoname, E. et al. "The Effect of Stimulus Frequency on the Analgesic Response to Percutaneous Electrical Nerve Stimulation in Patients with Chronic Low Back Pain", Anesthesia & Analgesia (Oct. 1999) 88: 841-6.|
|31||Ghoname, E. et al. "The Effect of the Duration of Electrical Stimulation on the Analgesic Response", Anesthesia & Analgesia (Jan. 1999) 88: S211.|
|32||Gopalkrishnan, P., et al., "Effect of Varying Frequency, Intensity, and Pulse Duration of Transcutaneous Electrical Nerve Stimulation on Primary Hyperalgesia in Inflamed Rats," Arch. Phys. Med. Rehabil., (Jul. 2000) vol. 81, pp. 984-990.|
|33||Gracanin, F., et al., "Optimal Stimulus Parameters for Minimum Pain in the Chronic Stimulation of Innervated Muscle," Arch. Phys. Med. Rehabil. (Jun. 1975) vol. 56, pp. 243-249.|
|34||Hamza, M. et al., "Effect of the Duration of Electrical Stimulation on the Analgesic Response in Patients with Low Back Pain", Anesthesiology (Dec. 1999), vol. 91, No. 6, pp. 1622-1627, Lippincott Williams & Wilkins, Inc.|
|35||Hamza, M.A., et al., "Effect of the Frequency of Transcutaneous Electrical Nerve Stimulation on the Postoperative Opioid Angalgesic Requirement and Recovery Profile," Anesthesiology, (Nov. 1999) V. 91, No. 5, pp. 1232-1238.|
|36||Han, J.S. et al., "Effect of Low- and High-Frequency TENS on Met-enkephalin-Arg Phe and dynorphin A immunoreactivity in human lumbar CSF," Pain, (1991) vol. 47, pp. 295-298, Elsevier Science Publishers B.V.|
|37||Healthronics HANS LY257 User Manual, Healthronics Pte Ltd., Singapore, 15 pages.|
|38||Innovative Healthcare: Electrotherapy Pain & Rehabilitation Product Solutions from Rehabilicare. [Includes product description of SporTX and Ortho DX], http://www.mvpdesign.com/sites/rehabilicare/all_products.htmi, (Aug. 2001), 3 pages.|
|39||Intelect Legend Stim Clinical Reference Manual, vol. 4 Intelect Legend Series, Chattanooga Group, Inc., (Jul. 2000) 25 pages.|
|40||Jette, D. U. et al.," Effect of Different Forms of Transcutaneous Electrical Nerve Stimulation on Experimental Pain," Physical Therapy, (Feb. 1986) vol. 66/No. 2, pp. 187-193.|
|41||Johnson, M. I. et al., "Analgesic Effects of Different Frequencies of Transcutaneous Electrical Nerve Stimulation on Cold-Induced Pain In Normal Subjects," Pain, (1989) 39, pp. 231-236, Elsevier Science Publishers B.V.|
|42||Johnson, M. I. et al., "Analgesic Effects of Different Pulse Patterns of Transcutaneous Electrical Nerve Stimulation on Cold-Induced Pain in Normal Subjects," Journal of Psychosomatic Research (1991) vol. 35, No. 2/3, pp. 313-321, Great Britain.|
|43||Johnson, M.I. et al., "An In-Depth Study of Long-Term Users of Transcutaneous Electrical Nerve Stimulation (TENS). Implications for Clinical Use of TENS," Pain (1991) 4, pp. 221-229, Elsevier Science Publishers B.V.|
|44||Katims, J.J. et al., "Transcutaneous Nerve Stimulation Frequency and Waveform Specificity in Humans," Appl. Neurophysiol. (1986) 49: pp. 86-91.|
|45||Landau, B. et al. "Neuromodulation Techniques for Medically Refractory Chronic Pain", Annu. Rev. Med. (Feb. 1993) 44: 279-87, Annual Reviews Inc.|
|46||Leem, J.W. et al., "Electrophysiological Evidence for the Antinociceptive Effect of Transcutaneous Electrical Stimulation on Mechanically Evoked Responsiveness of Dorsal Horms Neurons In Neuropathic Rats," Neuroscience Letters (1995) 192, pp. 197-200, Elsevier Science Ireland Ltd.|
|47||Lehmann T. et al. "Efficacy of Electroacupuncture and TENS In the Rehabilitation of Chronic Low Back Pain Patients", Pain (Sep. 1986) 26: 277-90, Elsevier Science Publishers B.V.|
|48||Liss, S. et al., "Physiological and Therapeutic Effects of High Frequency Electrical Pulses," Integrative Physiological and Behavioral Science, (Apr.-Jun. 1996) vol. 31, No. 2, pp. 88-94.|
|49||Marchand, S. et al., "Modulation of Heat Pain Perception by High Frequency Transcutaneous Electrical Nerve Stimulation (TENS)," The Clinical Journal of Pain (1991) 7: pp. 122-129, Raven Press Ltd., New York.|
|50||Model AWQ-104B Multi-Purpose Electronic Acupunctoscope Instruction Manual, 10 pages.|
|51||Moreno-Aranda, J. et al., "Electrical Parameters for Over-the-Skin Muscle Stimulation," J. Biomechanics, (1981) vol. 14, No. 9, pp. 579-585, Pergamon Press Ltd.|
|52||Moreno-Aranda, J. et al., "Investigation of Over-the-Skin Electrical Stimulation Parameters for Different Normal Muscles and Subjects," J. Biomechanics, (1981) vol. 14, No. 9, pp. 587-593, Pergamon Press Ltd., Great Britain.|
|53||O'Brien, W. J. et al., "Effect of Transcutaneous Electrical Nerve Stimulation on Human Blood B-Endorphin Levels," Physical Therapy, (Sep. 1984) vol. 64/No. 9, pp. 1367-1374.|
|54||Omura, Y., "Basic Electrical Parameters for Safe and Effective Electro Therapeutics [Electro-Acupuncture, TES, TENMS, (or TEMS), TENS and Electro Magnetic Field Stimulation with or without Drug Field] for Pain, Neuromuscular Skeletal Problems, and Circulatory Disturbances," Acupuncture & Electro Therapeutics Res., Int. J. (1987) vol. 12, pp. 201-225, Pergamon Journals Ltd., USA.|
|55||Omura, Y., Electrical Parameters for Safe and Effective Electro-Acupuncture and Transcutaneous Electrical Stimulation: Threshold Potentials for Tingling, Muscle Contraction and Pain: and How to Prevent Adverse Effects of Electro-Therapy, Acupuncture and Electro-Therapeutics Res., Int. J., (1985) vol. 10, Pergamon Press Ltd. USA.|
|56||Ordog, G.J., "Transcutaneous Electrical Nerve Stimulation versus Oral Analgesic: A Randomized Double-Blind Controlled Study in Acute Traumatic Pain," American Journal of Emergency Medicine, (Jan. 1987) vol. 5, No. 1, pp. 6-10.|
|57||PCT International Search Report for International Application No. PCT/US01/31441; mailed May 7, 2002; Applicant: Vertis Neuroscience, Inc., 8 pages.|
|58||PCT International Search Report for International Application No. PCT/US02/25551; mailed Feb. 18, 2003; Applicant: Vertis Neuroscience, Inc. 8 pgs.|
|59||Pointer F-3 Instruction Manual, ITO Co., Ltd., Tokyo, Japan (1999), 12 pages.|
|60||Radionics products brochure. "A Significant Breakthrough Using Pulsed Radiofrequency for Pain Management", Includes RF Lesion Generator System, Model RFG-3C Plus, (1997), Radionics. Burlington, MA, 10 pages.|
|61||Rehabilicare Ortho Dx product brochure. "Reduce Rehabilitation Time and Enhance Patient Comfort with Ortho Dx", Rehabilicare, New Brighton, MN, 2 pages.|
|62||Rehabilicare SMP-plus product brochure. "SMP-plus. The Pain Relief Solution for Hard to Treat Patients", Rehabilicare, New Brighton, MN (1999) 2 pages.|
|63||Rehabilicare SporTX Product Data Sheet, 1 page.|
|64||Rehabilicare SporTX Quick Set-Up Instructions, "SPORTX. Get back in the GAME!", Rehabilicare, New Brighton, MN, 2 pages.|
|65||Romita, V.V. et al., "Parametric Studies on Electroacupuncture-Like Stimulation in a Rat Model; Effects of Intensity, Frequency, and Duration of Stimulation on Evoked Antinociception," Brain Research Bulletin, (1997) vol. 42, No. 4, pp. 289-299, Elsevier Science Inc., USA.|
|66||Rooney, J.G. et al., "Effect of Variation in the Burst and Carrier Frequency Modes of Neuromuscular Electrical Stimulation on Pain Perception of Healthy Subjects," Physical Therapy, (Nov. 1992) vol. 72, No. 11, pp. 800-809.|
|67||Sluka, K.A. et al., "Treatment with either High or Low Frequency TENS Reduces the Secondary Hyperalgesia Observed After Injection of Kaolin and Carrageenan into the Knee Joint," Pain, (1998) 77, pp. 97-102, Elsevier Science B.V.|
|68||Somers, D.L., et al., "High-Frequency Transcutaneous Electrical Nerve Stimulation Alters Thermal but not Mechanical Allodynia Following Chronic Constriction Injury of the Rat Sciatic Nerve," Arch. Phys. Med. Rehabil., (1998) 79, pp. 1370-1376.|
|69||Starobinets, M. et al., "Analgesic Effect of High-Frequency and Acupuncture Like Transcutaneous Electric Stimulation of Nerve Fibers in Spinal Osteochondrosis," (Russian) Zhurnal Nevropatologii I Psikhiatrii Imeni S.S. Korsakova (1985) 85, (3), pp. 350-354.|
|70||U.S. Appl. No. 09/667,183, Leonard, filed Sep. 21, 2000.|
|71||U.S. Appl. No. 09/686,993, Gliner, filed Oct. 10, 2000.|
|72||U.S. Appl. No. 09/751,503, Gliner, filed Dec. 12, 2000.|
|73||U.S. Appl. No. 29/130,210, Leonard et al., filed Sep. 28, 2000.|
|74||U.S. Appl. No. 29/134,817, Bishay et al., filed Dec. 29, 2000.|
|75||Ulett, G. et al. "Electroacupuncture: Mechanisms and Clinical Application", Biological Psychiatry (Jul. 1998) 44: 129-38.|
|76||Van Doren, C.L., "Contours of Equal Perceived Amplitude and Equal Perceived Frequency for Electrocutaneous Stimuli," Perception and Psychophysics (1997) 59, (4), pp. 613-622.|
|77||White, P. et al. "Percutaneous Neuromodulation Therapy: Does the Location of Electrical Stimulation Effect the Acute Analgesic Response?", Anesthesia & Analgesia (Oct. 2000) 91: 1-6.|
|78||White, P. et al. "The Effect of Montage on the Analgesic Response to Percutaneous Neuromodulation.Therapy" Anesthesia & Analgesia (Feb. 2001) 92: 483-7.|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US7840272||May 22, 2006||Nov 23, 2010||Medrelief Inc.||Methods for modulating osteochondral development using bioelectrical stimulation|
|US8433386 *||Nov 1, 2010||Apr 30, 2013||Xialing Zhang||Subdermal needle electrode cable assembly having movable needle safety cover integral therewith|
|US8744549 *||Mar 27, 2013||Jun 3, 2014||Xialing Zhang||Subdermal needle electrode cable assembly having movable needle safety cover integral therewith|
|US8785196||Oct 14, 2010||Jul 22, 2014||Medrelief Inc.||Methods for modulating osteochondral development using bioelectrical stimulation|
|US20110105876 *||Nov 1, 2010||May 5, 2011||Xialing Zhang||Subdermal needle electrode cable assembly having movable needle safety cover integral therewith|
|US20130211225 *||Mar 27, 2013||Aug 15, 2013||Xialing Zhang||Subdermal needle electrode cable assembly having movable needle safety cover integral therewith|
|U.S. Classification||607/46, 607/115|
|International Classification||A61N1/34, A61N1/05|
|Cooperative Classification||A61N1/0502, A61N1/36017, A61N1/36021, A61N1/375, A61N1/0551|
|European Classification||A61N1/05L, A61N1/36E4, A61N1/05|
|Apr 19, 2001||AS||Assignment|
Owner name: VERTIS NEUROSCIENCE, INC., WASHINGTON
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BISHAY, JON M.;LEONARD, PAUL C.;MIAZGA, JAY M.;REEL/FRAME:011725/0781;SIGNING DATES FROM 20010326 TO 20010402
|May 23, 2003||AS||Assignment|
|Dec 11, 2008||FPAY||Fee payment|
Year of fee payment: 4
|Dec 28, 2012||FPAY||Fee payment|
Year of fee payment: 8